Novartis NVS announced new phase II data on IND/GLY/MF (QVM149) at the 2019 annual international congress of the American Thoracic Society (ATS).
IND/GLY/MF is an investigational, once-daily, fixed dose combination asthma treatment containing indacaterol acetate, glycopyrronium bromide and mometasone furoate, delivered with the dose-confirming Breezhalerinhalation device.
The data from the two phase II studies showed that IND/GLY/MF was superior to the comparators — salmeterol/fluticasone propionate (a standard-of-care treatment) and placebo. In one study, IND/GLY/MF was superior to the standard of care in terms of lung function. In another phase II study, IND/GLY/MF was superior to placebo in lung function improvement, irrespective of administration time of morning or evening.
The combination met the primary endpoint in the phase II CQVM149B2208 study. IND/GLY/MF demonstrated a favorable safety and tolerability profile in both phase II studies.
While phase III trials are ongoing, Novartis plans to present more data and analyses to address the clinical and regulatory path forward for IND/GLY/MF.
Separately, the company also shared inputs on its transformation strategy at its annual Meet Novartis Management event. While the strong performance of Cosentyx and Entresto continue to boost the Pharmaceuticals business unit, the company plans to launch five blockbuster candidates in core therapeutic areas over the next two years — Mayzent, Zolgensma, Brolucizumab (RTH258), Ofatumumab (OMB157), and Fevipiprant (QAW039). The company is all set to strengthen its oncology portfolio.
Novartis has multiple 2019 pipeline milestones, including six major readouts, which should further accelerate growth.
The company also provided an update on its generic arm, Sandoz. Per the company, while the U.S. market is being affected by pricing pressure, approximately 70% of Sandoz sales come from international territories, where sales are growing.
The company is reshaping the portfolio with the divestment of the U.S. oral solids and dermatology portfolio (expected to be completed in 2019). The biosimilars portfolio looks solid with eight biosimilars already in the market and more than ten in the pipeline.
Novartis’ stock has lost 2.2% in the year so far against the industry's 0.4% growth.
The company is currently restructuring its business to become a core drug-focused company, powered by data and digital technologies. The separation of the Alcon business is a step in the right direction, as the business was not performing as per management’s expectations.
Zacks Rank & Stocks to Consider
Novartis currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks are Bristol-Myers Squibb Co. BMY, Roche RHHBY and Celgene Corp. CELG. While Bristol-Myers sports a Zacks Rank #1 (Strong Buy), the other two carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Bristol-Myers’ earnings per share estimates have increased from $4.78 to $5.03 for 2020 in the past 60 days.
Roche’s earnings per share estimates have increased from $2.35 to $2.40 for 2019 in the past 60 days.
Celgene’s earnings estimates have moved up 3 cents to $10.74 over the past 30 days.
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